Full Text CA-92-18 CONTEMPORARY APPROACHES TO OVARIAN CANCER BIOLOGY RESEARCH NIH GUIDE, Volume 21, Number 21, June 5, 1992 RFA: CA-92-18 P.T. 34 Keywords: Cancer/Carcinogenesis Etiology Biology, Cellular Biology, Molecular National Cancer Institute Letter of Intent Receipt Date: July 17, 1992 Application Receipt Date: October 9, 1992 PURPOSE The Cancer Biology Branch of the Division of Cancer Biology, Diagnosis, and Centers (DCBDC) of the National Cancer Institute (NCI) invites applications for grants to study the basic tumor biology of ovarian cancer of epithelial and non-epithelial origin. Although interest in research on these malignancies has increased somewhat in the past several years, there remains a significant lack of understanding about the underlying factors, both intrinsic (genetic and cellular) and extrinsic (epigenetic), that contribute to the development of ovarian cancer. This initiative is designed to foster the application of recent advances in molecular and cellular biology, particularly those that use cells derived from samples of normal and malignant human tissues or that aid in development and use of animal models, to study the generation and spread of ovarian malignancies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Contemportary Approaches to Ovarian Cancer Biology Research, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238. ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this RFA will be by National Institutes of Health (NIH) individual research grants (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. The anticipated award date will be August 1, 1993. FUNDS AVAILABLE Approximately $1,500,000 in total costs per year for four years will be committed to fund applications submitted in response to this. It is anticipated that eight to ten awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Ovarian cancer is the fourth leading cause of cancer deaths in women. More than 20,000 new cases of ovarian cancer will be diagnosed this year. If detected at an early stage, these malignancies respond well to therapy. However, because early detection is difficult, the malignancies are frequently at an advanced stage when discovered; consequently, many affected women succumb to the disease. The Cancer Biology Branch supports a spectrum of basic research on how cancer cells differ from the normal counterparts and the progression from early neoplastic changes to greater degrees of malignancy. These studies range from investigation of the molecular biology of human or animal tumor cell behavior to analysis of cells in the context of the tissue of origin or the tissue in an animal model. This research may ultimately help to pinpoint steps in the malignant process at which therapeutic intervention is possible and to identify markers for detection, diagnosis, and prognosis. The base of information about the biology of ovarian cancer is limited, and few facts about its development, particularly at the early stages, are known. To define the areas of research that might be expected to have the greatest impact on the understanding of this malignancy, a working group was convened in December, 1991. The working group concluded that many advances in molecular and cell biology and in the development of in vitro and in vivo models for various malignancies are available to apply to ovarian malignancies. The group also raised a number of questions that could be addressed. For example, in ovarian tumors are there aberrations in the array of hormonal, autocrine, and paracrine factors that maintain the integrity and function of normal ovarian tissues? What are the early genetic or epigenetic changes in ovarian cancer, and what are the functional results of these changes? Are there early, malignancy-associated alterations in normal surface or adhesive properties of ovarian cells that promote the unusual dissemination characteristics of the disease? Is there a defined pre-malignant or latent state in the formation of ovarian cancer, and, if so, what factors contribute to malignant progression? Such questions are but a few of the possible lines of inquiry that might be fruitful ones for understanding this disease. The preliminary observations about ovarian cancer suggest many intriguing features that are unique to these malignancies. Information is needed about the intrinsic and extrinsic factors that contribute to the development of ovarian malignancies. The potential now exists to apply the techniques used for study of other solid tumors to ovarian cancer to begin to establish a foundation of basic knowledge about this disease. This RFA is intended to encourage a variety of investigator-initiated research projects. It may include collaborations among basic and clinical scientists, and it likely will embrace an array of molecular and cellular approaches. Evidence of the establishment of reliable cellular systems or relevant models should be included in the applications. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS The following is a statement of NIH and ADAMHA policy regarding the inclusion of women and minorities in study populations. Applications that are responsive to this RFA will, by definition, meet the requirement for inclusion of women. The inclusion of minorities must be addressed in applications submitted responding to this RFA. NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in the Research Plan, Sections 1-4, AND summarized in Section 5, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by July 17, 1992, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Cheryl L. Marks Program Director for Molecular Biology Tumor Biology Program Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza South, Room 630 Bethesda, MD 20892-9904* Telephone: (301) 496-7028 FAX: (301) 402-1037 *Applicants who use express mail or a courier service are advised to use the following street address: Executive Plaza South, Room 630 6120 Executive Blvd. Rockville, MD 20852 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892-9912, telephone (301) 496-7441. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title, "Contemporary Approaches to Ovarian Cancer Biology Research," must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, includ- ing the Checklist, and three signed, exact, clear, single-sided photocopies, in one package with the appendices to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-9912** At the time of submission, two additional copies of the application must also be sent to: Referral Officer Review Logistics Branch Division of Extramural Activities National Cancer Institute Westwood Building, Room 848 5333 Westbard Avenue Bethesda, MD 20892-9912* *Applicants who wish to use express mail or a courier service should change the zip code to 20816. Applications must be received by October 9, 1992. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by DRG staff for completeness. Incomplete applications will be returned to the applicant without further consideration. Complete applications will be evaluated by NCI program staff to determine responsiveness to the program requirements and criteria stated in this RFA. If the application is not responsive to the RFA, NCI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. If the number of applications is large compared to the number of awards to be made, NCI may conduct a preliminary scientific peer review (triage) to eliminate those that are clearly not competitive. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. The factors considered in evaluating the scientific merit of each response to this RFA will be: o scientific and technical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff; o availability of the resources, including reliable in vivo or in vitro models, necessary to perform the research; o appropriateness of the proposed budget and project duration in relation to the proposed research; AWARD CRITERIA The anticipated date of award is August 1, 1993. In addition to the technical merit of the application, the NCI will consider how well the proposed research meets the goals and objectives of the program as described in the RFA. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged and are to be directed to the program director listed below. NCI program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding program issues to: Dr. Cheryl L. Marks Program Director for Molecular Biology Tumor Biology Program Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza South, Room 630 Bethesda, MD 20892 Telephone: (301) 496-7028 FAX: (301) 402-1037 Direct inquiries regarding fiscal and administrative matters to: Mr. Robert Hawkins Grants Management Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 13 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.396, Cancer Biology. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |